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DECISION No

DECISION No. 1847/2003/QD-BYT OF MAY 28, 2003 PROMULGATING THE REGULATION ON WRITING OUT PRESCRIPTIONS AND SELLING DRUGS THEREON

THE MINISTER OF HEALTH

Pursuant to the Law on Protection of the People’s Heath, promulgated on July 11, 1989, and the Regulation on preventive and curative medicines for human beings, issued together with Decree No. 23/HDBT of January 24, 1991 of the Council of Ministers;

Pursuant to the Government’s Decree No. 68/CP of October 11, 1993 defining the functions, tasks, powers and organizational apparatus of the Ministry of Health;

At the proposals of the director of the Therapy Department and the director of Vietnam Pharmaceutical Management Department,

DECIDES:

Article 1.- To issue together with this Decision the Regulation on writing out prescriptions and selling drugs thereon.

Article 2.- The Regulation on writing out prescriptions and selling drugs thereon shall apply to the writing out of prescriptions as well as the sale and provision of drugs thereon for out-patient treatment, and shall not apply to the writing out of prescriptions for in-patient treatment as well as the prescription and the sale of traditional medicines.

Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette and replaces the Health Minister’s Decision No. 488/BYT-QD of April 3, 1995 promulgating the provisional Regulation on writing out prescriptions and selling drugs thereon.

Article 4.- The director of the Office, the chief inspector and the director of the Therapy Department under the Health Ministry, the director of Vietnam Pharmaceutical Management Department, the general director of Vietnam Pharmaceutical Corporation, the directors of hospitals and institutes with hospital beds under the Ministry, the directors of the provincial/municipal Health Services and the heads of health sections of branches shall have to implement this Decision.

Minister of Health

TRAN THI TRUNG CHIEN

REGULATION ON WRITING OUT PRESCRIPTIONS AND SELLING DRUGS THEREON

(Issued together with Decision No. 1847/2003/QD-BYT of May 28, 2003)

Chapter I

GENERAL PROVISIONS

Article 1.- Doctors may inscribe treatment indications for patients in the prescriptions or medical books, referred collectively to as the prescription. Prescriptions are doctors’ documents indicating the use of drugs for patients and constitute a legal basis for indication of the use, sale and provision of drugs on prescriptions.

Article 2.- Scope and subjects of application of this Regulation:

1. Scope of application: The prescription of drugs as well as the sale or provision of drugs on prescriptions for out-patient treatment.

2. Subjects of application:

- Doctors providing medical examination and treatment at State-run, private, semi-public, people-founded, foreign-invested, as well as charitable and humanitarian medical examination and treatment establishments.

- Drugs sellers at State-run and private pharmaceutical practicing establishments.

Article 3.- Conditions on drug prescribers and drug sellers:

1. Drug prescribers must meet the following conditions:

- Being practicing their profession at State-run establishments, having medical university diplomas and being assigned by the heads of the establishments to provide medical examination and treatment.

- Being practicing their profession at private, semi-public, people-founded or foreign-invested (non-public) establishments which are qualified for providing medical examination and treatment as prescribed in the Ordinance on Private Medical and Pharmaceutical Practices and relevant legal documents, and being assigned by the heads of the establishments to render medical examination and treatment.

2. Drugs sellers: The current regulations on pharmaceutical practice, issued by the Ministry of Health, shall apply.

3. For provinces having mountainous and deep-lying and/or high-land areas, off-shore islands, where the contingent of medical workers is still inadequate:

- The provincial/municipal Health Services shall authorize the directors of medical centers to appoint drug prescribers and drug sellers to suit the local situation.

- Private medical establishments shall comply with the guidance on medical and pharmaceutical practice issued by the Ministry of Health.

Article 4.- Tables of drugs to be prescribed and sold on prescriptions:

1. Addictive drugs.

2. Psychotropic medicines and pre-substances used as medicines.

3. Poisonous medicament of Tables A and B.

3. Antibiotics

4. Endocrine drugs (except for contraceptives).

5. Cardiovascular medicines.

6. Transfusion liquids.

Chapter II

PRESCRIPTIONS AND WRITING OUT PRESCRIPTIONS

Article 5.- Medical examination and treatment establishments must have all the following prescription and book forms:

1. Prescriptions used for ordinary drugs, poisonous medicament, psychotropic medicines and pre-substances used as drugs (according to Form No. MS: 17D/BV-01 issued together with Decision No. 4069/QD-BYT of September 28, 2001 promulgating forms of medical records).

2. Prescriptions on addictive drugs.

3. Books on treatment of chronic diseases. For schizophrenics and epileptics undertaking out-patient treatment, form MS: 03D/BV-01 issued together with Decision No. 4069/QD-BYT of September 28, 2001 promulgating forms of medical records shall be used.

4. Report forms.

Article 6.- Drug prescribers shall be accountable for their prescriptions for patients and strictly comply with the following regulations:

1. To prescribe drugs only for the diseases they are assigned to provide medical examination and treatment or diseases within the practicing scope inscribed in their certificates of practicing qualification, granted by competent State agencies.

2. To prescribe drugs only after:

- Directly making examination.

- Thoroughly grasping indications, contraindications, usage, dosage, interaction, incompatibility, side-effects and harmful reaction of the drugs prescribed for patients.

3. Not to prescribe drugs in the following cases:

- Not for the purposes of disease prevention and/or treatment.

- At unreasonable requests of patients.

Article 7.- Provisions on writing out prescriptions:

1. To fill in all blanks printed in the prescriptions. Prescriptions shall be written out with pens or ballpoint pens in an intelligible manner.

2. For diseased children of under 24 months: To inscribe the months of age and names of their fathers or mothers.

3. To accurately inscribe the addresses of patients with house numbers, streets or villages and communes.

4. To inscribe the drugs’ appellations according to international drug appellation (DCI) for drugs having 01 component; to inscribe the accurate appellations of specific drugs for drugs having many components.

5. To inscribe the drug appellations, concentration, quantity, dose, dose for 24 hours, and usage of each kind of drug.

6. The quantity of poisonous medicament of Table A and addictive drugs must be inscribed in word with the first letter being capitalized.

7. The quantity of poisonous medicament of Table B, psychotropic medicines and pre-substances used as drugs, if indicated in one digit, must be inscribed with the numeral 0 added before such digit.

8. To sign at the side if prescribing drugs in excess of the maximum dose or correcting the prescriptions.

9. Addictive drugs must be prescribed in separate prescriptions, each prescription shall be made in two copies, one kept by patients and the other by the drug store, and its counterfoil shall be kept by medical examination and treatment establishments.

10. To cross the blank section of the prescriptions. To sign, clearly inscribe their academic titles and full names, and affix the seals of the clinics or hospitals (if the clinics or hospitals have their own seals).

Article 8.- It is forbidden to prescribe drugs for use beyond the number of days stipulated below:

- Seven (07) days for addictive drugs. Particularly for morphine hydrochloride of 10 mg/1ml/ampoule, the number of days must not exceed five (05) for cancer patients taking a dose of over 30 mg/day.

- Ten (10) days for poisonous medicament of Tables A and B and psychotropic medicines.

Article 9.- For chronic diseases which require the prescription of special drugs for long-term use, books on out-patient treatment of chronic diseases shall be used instead of prescriptions. Doctors may prescribe drugs with a quantity adequate for patients to use in 01 month.

Article 10.- For tuberculosis patients who buy drugs by themselves, the prescription and the sale of drugs shall be carried out as for chronic diseases. For tuberculosis patients using drugs under the national program on tuberculosis prevention and combat, the prescription and the provision of drugs shall comply with the guidance of the national program on tuberculosis prevention and combat.

Article 11.- For mental disease sufferers living in remote or deep-lying areas and areas meeting with travel difficulties, it is allowed to prescribe and provide drugs each time for 01 month (30 days). The relatives of these patients, the health stations of communes or wards where they live or the health sections of the agencies where they work shall have to buy or receive drugs for them and inscribe their full names and number of their people’s identity cards in the prescriptions to be archived. The doctors shall decide on whether the mental patients are allowed to receive drugs by themselves or not.

Article 12.- Prescriptions shall be valid for drug purchase at all lawful drug-selling establishments throughout the country within 10 days as from the date they are written out.

Article 13.- The provincial/municipal Health Services shall assign establishments to sell addictive drugs to patients. Annually, medical examination and treatment establishments shall have to register with addictive drug-selling establishments the signatures of doctors who shall prescribe addictive drugs. Prescriptions of addictive drugs shall be valid for drug purchase only at drug-selling establishments where the signatures of the drug prescribers are registered.

Chapter III

SELLING DRUGS ON PRESCRIPTIONS

Article 14.- Drug-selling establishments shall have to print all books on the purchase-in and sale-out of addictive drugs, poisonous medicament, psychotropic medicines and pre-substances used as drugs according to the Health Ministry’s regulations and to comply with the following:

1. To strictly manage them from the printing, distribution to the use thereof.

2. To immediately notify the loss of books, if any, to their superior managing agencies.

3. To keep books and prescriptions on addictive drugs at their units for at least 05 years as from the date the last page thereof is used. Upon the expiry of the duration for keeping books and prescriptions, to set up councils for destruction of these books and prescriptions, with records thereon.

Article 15.- Drug sellers shall only be allowed to sell drugs permitted for circulation by the Health Ministry and must not sell drugs subject to prescription without doctors’ prescriptions.

Article 16.- Drug sellers shall have to sell drugs strictly according to prescriptions. If the drugs’ appellations, concentrations, contents and quantity inscribed in the prescriptions are not clear, they shall ask the drug prescribers so as to avoid misunderstanding. Drug sellers may refuse to sell drugs on prescriptions in the following cases:

1. The prescriptions are invalid.

2. There are any mistakes or doubts regarding the prescriptions.

3. The prescriptions are made not for the purposes of disease treatment.

Article 17.- Drug sellers shall have to sell the drugs as prescribed and must not change drugs at their own will. In cases where special drugs of different appellations have the same pharmaceutical substances, contents, concentrations and preparation forms, drug sellers may substitute them when so agreed by the purchasers or the drug prescribers and inscribe the appellations, contents, concentrations and quantity of the substituted drugs in the prescriptions.

Article 18.- Drug sellers may sell some types of psychotropic medicines and pre-substances used as medicines according to medical books:

1. For ephedrine of 10mg/pill, no more than 10 pills each time.

3. For ephedrine of 10mg/ampoule, no more than 5 ampoules each time.

3. For phenylpropanolamin of 25mg/pill, no more than 10 pills each time.

It is forbidden to sell drugs to children aged under 15.

Article 19.- After selling drugs, the drug sellers shall have to:

1. Clearly inscribe the quantity of sold drugs in the prescriptions or medical books. If they do not sell all types of drugs inscribed in the prescriptions, they shall inscribe the sold quantity in the prescriptions for patients to buy the remainder at other places.

2. To inscribe addictive drugs, poisonous medicament of Tables A and B, psychotropic medicines and pre-substances used as medicines in books on the sale-out of drugs (books on the sale-out and purchase-in of addictive drugs, poisonous medicament of Tables A and B and psychotropic medicines shall comply with the forms set by the Health Ministry).

3. To keep the originals of the prescriptions of addictive drugs.

Article 20.- Doctors must not sell drugs. Medical examination and treatment establishments are strictly forbidden to sell and/or purchase drugs besides the prescribed volume of drugs for emergency treatment.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 21.- The subjects defined in Article 2 of this Regulation shall be subject to the inspection and examination by the Health Ministry and the provincial/municipal Health Services. If committing violations, they shall, depending on the seriousness of their violations, be disciplined, administratively sanctioned or examined for penal liability; if causing damage, they must pay compensation therefor according to law provisions.

Article 22.- Medical examination and treatment establishments and drug-selling establishments must immediately report to their superior managing agencies on all violations of the Regulation on writing out prescriptions and selling drugs thereon.

Article 23.- The director of the Therapy Department, the director of Vietnam Pharmaceutical Management Department and the chief inspector of the Ministry shall have to guide, inspect and examine the implementation of this Regulation nationwide. The directors of provincial/municipal Health Services shall have to organize, inspect and examine the implementation of this Regulation in their respective localities.

Article 24.- In the course of implementing the Regulation on writing out prescriptions and selling drugs thereon, if meeting with any difficulties, units and localities should report them to the Health Ministry (the Therapy Department and Vietnam Pharmaceutical Management Department) for timely and proper study, amendment and supplementation.

Minister of Health

TRAN THI TRUNG CHIEN